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Chief Quality Officer

3 weeks ago

San Diego, California, United States BioPhase Solutions Full time
Job Description:
BioPhase Solutions is seeking a highly qualified Chief Quality Officer - GMP Manufacturing to join our team. As a key member of our leadership team, you will be responsible for leading our quality management system and ensuring compliance with global regulations.

About the Position:
This is a senior-level role that requires extensive experience in quality assurance, particularly in cGMP manufacturing environments. You will oversee all aspects of quality assurance, including documentation, procedures, and training programs. Your primary responsibility will be to ensure adherence to quality standards throughout the product lifecycle, collaborating with cross-functional teams to address compliance issues and implement proactive measures.

Key Responsibilities:
- Lead the Quality Assurance team, focusing on continuous improvement and accountability.
- Develop and implement strategic quality plans aligned with company goals and regulatory requirements.
- Collaborate with cross-functional teams to ensure adherence to quality standards throughout the product lifecycle.
- Oversee the development and maintenance of a compliant QMS in line with GMP standards.

Qualifications:
- Bachelor's degree in Chemistry or a related life science field; advanced degree preferred.
- Minimum of 15 years in Quality Assurance for GMP manufacturing within biotech or pharmaceutical industries.
- In-depth knowledge of cGMP regulations, QMS, and industry best practices; familiarity with GCP, GLP, and pharmacovigilance regulations is beneficial.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with internal teams and external partners (CDMOs, CROs, and vendors).
- Experience hosting regulatory inspections (FDA, EMA, etc.) is highly desirable.
- Strong organizational skills, critical thinking, and meticulous attention to detail.

Estimated Salary Range: $180-230K per year.